Fortrea is currently hiring for the position of Regulatory Operations Assistant I in Mumbai, India. This opportunity is ideal for B.Pharm, M.Pharm, Pharmaceutics, Analytical Science, and Life Sciences graduates who want to build a career in Regulatory Affairs, Regulatory Operations, and pharmaceutical documentation management.
Candidates with 0-3 years of experience in regulatory affairs, analytical science, QA, pharmaceutics, or drug development processes are encouraged to apply. This role provides exposure to global regulatory submissions including US, EU, Japan, and Rest-of-World (ROW) health authorities.
If you are looking for a regulatory affairs job in Mumbai, this role offers excellent learning opportunities in GxP compliance, regulatory documentation, and pharmaceutical product lifecycle management.
Job Details
| Parameter | Details |
|---|---|
| Position | Regulatory Operations Assistant I |
| Company | Fortrea |
| Location | Mumbai, India |
| Job Type | Full-time |
| Experience | 0โ3 Years |
| Qualification | B.Pharm / M.Pharm / Life Sciences |
| Application Deadline | 10 March 2026 |
Key Responsibilities
The Regulatory Operations Assistant will support regulatory submission and documentation activities for pharmaceutical products.
Major responsibilities include:
- Preparation, compilation, revision, and approval of regulatory submission documents
- Supporting submissions to US FDA, EMA (EU), Japan PMDA, and other global health authorities
- Maintaining regulatory documentation and specifications
- Ensuring compliance with GMP, GLP, GDP, cGMP and ICH guidelines
- Supporting analytical testing documentation and quality review
- Managing electronic document management systems (EDMS)
- Maintaining training documentation and regulatory records
- Supporting onboarding and mentoring of new associates
- Coordinating regulatory submission activities across teams
Analytical & Technical Responsibilities
The role may involve supporting analytical documentation related to:
- Assay analysis of API and finished products
- Related substances and impurity analysis
- Residual solvent testing
- Dissolution and content uniformity testing
- Blend uniformity studies
- Cleaning validation documentation
- Process validation documentation
Candidates may also work with analytical instruments such as:
- HPLC
- UPLC
- Gas Chromatography (GC)
- Karl Fischer titration
- Dissolution apparatus
- Particle size analyzer
- pH meter and analytical balance
Required Qualifications
Applicants must have one of the following qualifications:
- B.Pharm (Bachelor of Pharmacy)
- M.Pharm
- Life Sciences degree
- Equivalent science qualification
Additional preferred qualifications:
- Diploma or certification in Regulatory Affairs
- Knowledge of Regulatory Information Management Systems (RIMS)
- Familiarity with Document Management Systems
Required Skills
Ideal candidates should possess:
- Understanding of pharmaceutical product lifecycle
- Knowledge of GxP and ICH-GCP guidelines
- Strong documentation and review skills
- Good analytical thinking and attention to detail
- Proficiency in Microsoft Office tools
- Effective communication and organizational skills
- Ability to work in a global regulatory environment
Salary (Estimated)
Based on industry benchmarks for regulatory operations roles in Mumbai:
โน4 LPA โ โน7 LPA
Salary may vary depending on experience, qualifications, and company policy.
Why Join Fortrea?
Fortrea is a leading global clinical research and regulatory services organization that supports pharmaceutical and biotechnology companies across drug development.
Benefits of working with Fortrea include:
- Exposure to global regulatory submissions
- Experience with international health authority requirements
- Opportunity to work in clinical research and regulatory operations
- Professional development in drug development lifecycle
- Collaborative global regulatory teams
How to Apply
